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Completed

NCT Number: NCT02618278

Physiotherapy for Sciatica; Is Earlier Better?

This study aims to evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. 80 people with sciatica will take part in the study, half of which will receive physiotherapy 2 weeks after seeing their G.P. The other half will receive physiotherapy at the usual time, around 6 weeks after seeing their G.P.

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Key information

About this study

Sciatica is a relatively common problem which is often caused by nerve compression or irritation due to a lower back (Lumbar) disc prolapse. The problem is likely to improve in time as the body heals itself. However, this can take many months or sometime years. Sciatica can be a very painful condition, it may cause pins and needles, numbness or weakness in the legs affected. This, can cause great difficulty for people carrying out normal day to day activities.

Physiotherapy is often used to help people with sciatica but in many places in the United Kingdom it can take many weeks or months to begin therapy.

This study aims to see if having physiotherapy at 2 weeks after the patient has seen their G.P helps them get back to normal day to day function. This will be compared with another group of patients who will have physiotherapy at the 'usual' time of around 6 weeks after they have seen their G.P.The investigators will also be interviewing participants for their views of sciatica and physiotherapy. Each patient will receive a goal orientated physiotherapy management programme with achievement of those goals acting as secondary outcomes. Primary outcomes are feasibility objectives including patient recruitment rates, acceptability of outcome measures and intervention and rates of adverse events.

This is a pilot study which means that the investigators won't be directly comparing the 2 groups, but seeing if doing a full-scale study in the future is going to be feasible.The investigators will do this by measuring several different things, such as whether patients want to take part in the study or not, whether the tests the investigators will perform are the right tests and to see if the patients and physiotherapists find the treatment useful.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18-70 years of age with unilateral LRS defined as pain and or sensory disturbance and or weakness in a dermatomal and or myotomal distribution.

Exclusion criteria

  • Patients with bilateral LRS.
  • Patients with 'red flag' signs and symptoms of potential serious pathology.
  • Cancer at the time of the study.
  • Proven vascular claudication.
  • Cauda Equina Syndrome (CES).
  • Spinal fracture within the last 3 months.
  • Chronic regional pain syndromes.
  • Recent lower limb fracture.
  • CVA with physical or psychiatric disability.
  • Poor English skills (necessitating the use of an interpreter and invalidating outcomes measures-ODI).
  • Other significant co-morbidities preventing regular attendance at physiotherapy clinics.
  • Patients with significant mental health problems for which treatment adherence may be difficult or psychologically disabling.

Treatment and study plan

Physiotherapy

Other

The aims of physiotherapy are to promote physical and psychological health for the patient, and in doing so promote and improve function. In light of the evidence to suggest spontaneous resorption of the disc fragment occurs, physiotherapy provides support and guidance for the patient to manage their symptoms whilst resorption takes place. The physiotherapy regimen will be tailored to the individuals' requirements. It will be goal orientated, and assessed using a biopsychosocial approach based on 7 different elements; neurological dysfunction, motor control of movement of the lumbar spine and pelvis, movement restriction in the lumbar spine and pelvis, psychological barriers to recovery, advice and education, functional-based exercise and pain.

Primary outcomes

  1. Ability to recruit patients

    Time frame: 26 weeks

    Ability to recruit patients within the 26 week limit

  2. Patients willing to be randomised

    Time frame: 26 weeks

    The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.

  3. Ability to initiate treatment

    Time frame: 2 weeks for intervention arm, 6 weeks for control

    Demonstrate the ability to organise physiotherapy appointments expeditiously

  4. Ensure patient safety

    Time frame: 52 weeks

    Record all adverse and serious adverse events

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks

    self-rated disability 0/100

  2. EQ5D-5L

    Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks

    General health measurement

  3. Back & leg pain

    Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks

    Self-reported back and leg pain

  4. Goal achievement

    Time frame: 26 weeks

    Patient will rate whether their goal(s) have been achieved

Sponsors and collaborators

Lead sponsor

Michael Reddington

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?

Acronym: POLAR

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2015
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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